Tilmicosin - MIB #80

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Date Revised: 2011-12

Approved Brands

1. PULMOTIL PREMIX contains tilmicosin at 200 g/kg (Elanco)
2. TILMOVET PREMIX contains tilmicosin at 200 g/kg (Huvepharma)

Approved for use

In meal or pellet feed for swine and feedlot beef cattle.

Approved claims

For swine - Claims 1 and 2
For feedlot beef cattle - Claim 3

Note: TILMOVET PREMIX is approved for use in feeds for swine only.

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Claim 1: As an aid in reducing the severity of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae and Pasteurella multocida when fed to pigs approximately 7 days prior to anticipated disease outbreak.

Level of Drug:

200 mg/kg (0.02%) in the complete feed

NOTE to User (Not required on feed labels): To promote responsible use and limit the development of antimicrobial resistance, consult your veterinarian and use only when factors associated with outbreaks of SRD and Glasser's Disease (such as herd health status, target pig population, herd management and environment factors, etc.) have been carefully considered.

Directions:

The medicated feed is to be fed continuously as the sole ration for a 21 day period beginning approximately 7 days before an anticipated disease outbreak.

Warning:

1. Treated swine must not be slaughtered for use in food for at least 14 days after the latest treatment with this medicated feed.
2. When mixing and handling this medicated feed, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention (Required on Premix and Supplement labels only).
3. Keep out of reach of children. (Required on Premix and Supplement labels only).
4. To limit the development of antimicrobial resistance, this medicated feed should only be used in swine at a high risk of developing SRD or Glasser's Disease.

Caution:

1. Do not use in any feed containing bentonite. (Required on Premix and Supplement labels only).
2. Do not use in animals hypersensitive to tilmicosin.
3. Do not allow horses or other equines access to feeds containing tilmicosin. Ingestion of tilmicosin by these species is known to be toxic.
4. The safety of tilmicosin has not been established in boars used for breeding.

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Claim 2: As an aid in reducing the severity of porcine polyserositis and arthritis associated with Haemophilus parasuis (Glasser's Disease) when fed to pigs approximately 7 days prior to anticipated disease outbreak.

Level of Drug:

400 mg/kg (0.04%) in the complete feed

NOTE to User (Not required on feed labels): To promote responsible use and limit the development of antimicrobial resistance, consult your veterinarian and use only when factors associated with outbreaks of SRD and Glasser's Disease (such as herd health status, target pig population, herd management and environment factors, etc.) have been carefully considered.

Directions:

The medicated feed is to be fed continuously as the sole ration for a 21 day period beginning approximately 7 days before an anticipated disease outbreak.

Warning:

1. Treated swine must not be slaughtered for use in food for at least 14 days after the latest treatment with this medicated feed.
2. When mixing and handling this medicated feed, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. (Required on Premix and Supplement labels only).
3. Keep out of reach of children. (Required on Premix and Supplement labels only).
4. To limit the development of antimicrobial resistance, this medicated feed should only be used in swine at a high risk of developing SRD or Glasser's Disease.

Caution:

1. Do not use in any feed containing bentonite. (Required on Premix and Supplement labels only).
2. Do not use in animals hypersensitive to tilmicosin.
3. Do not allow horses or other equines access to feeds containing tilmicosin. Ingestion of tilmicosin by these species is known to be toxic.
4. The safety of tilmicosin has not been established in boars used for breeding.

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Claim 3: For the reduction of bovine respiratory disease (BRD) morbidity associated with Mannheimia haemolytica, Pasteurella multocida and/or Histophilus somni in groups of feedlot beef cattle experiencing an outbreak of BRD.

Level of Drug:

At a level in supplements, premixes and complete feeds that, when used as directed, supplies 12.5 mg/kg of body weight(s) in the daily total diet.

NOTE to User (Not required on feed labels): To promote responsible use and limit the development of antimicrobial resistance, consult your veterinarian and use this medication in feedlot beef cattle when:

1. Clinical BRD has been diagnosed in at least 10% of animals in the group to be treated; AND
2. Treatment is initiated within the first 45 days of arrival in the feedlot; AND
3. Medication is limited to one single period of 14 consecutive days of treatment.

Directions:

Feed continuously as a sole ration to feedlot beef cattle for a 14 day period in the total diet (total mixed ration).

Feed labels will be required to state the body weight(s) of the beef cattle being fed.

Note: Supplements, premixes, and grain rations must be thoroughly mixed in the total diet before use and must not be feed undiluted.

Warning:

1. Treated cattle must not be slaughtered for use in food for at least 28 days after the latest treatment with this medicated feed.
2. To limit the development of antimicrobial resistance, this medicated feed should only be used in feedlot beef cattle at a high risk of developing BRD.
3. When mixing and handling this medicated feed, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. (Required on Premix and Supplement labels only).
4. Keep out of reach of children. (Required on Premix and Supplement labels only).

Caution:

1. Do not use in any feed containing bentonite. (Required on Premix and Supplement labels only).
2. The safety of this medicated premix in pre-ruminant calves has not been established.
3. The effects of tilmicosin on bovine reproduction performance, pregnancy and lactation have not been determined.
4. Do not use in animals hypersensitive to tilmicosin.
5. Do not allow horses or other equines access to feeds containing tilmicosin. Ingestion of tilmicosin by these species is known to be toxic.

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Accepted Compatibilities

Tilmicosin is compatible with the following drug/drug combinations. For details, refer to the MIB as indicated.

Number	Medicated ingredients	For use in feed for
1.	Monensin Sodium (MIB #57, Claim # 3)	Feedlot beef cattle